Kornimate/medical-research-clean huggingface dataset:
the breastrial:breast reconstruction evaluation using acellular dermal matrix as a sling trial

Conditions: Breast Cancer; Reconstructive Surgery

Summary: primary hypothesis: 1. alloderm and dermamatrix have comparable complication rates when used for staged breast reconstruction secondary hypotheses: 1. the complication rates following staged breast reconstruction using alloderm or dermamatrix are higher if the patient requires radiation compared to those who do not require radiation. 2. dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation. 3. dermal matrix incorporation is no different when comparing alloderm and dermamatrix specific aims: 1. evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation 2. compare the complication rates between the two types of acellular dermal matrix 3. evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation. 4. compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation


Eligibility criteria:
inclusion criteria: * plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy * female gender * age between 18 and 80 * consent to participate in the study exclusion criteria: * patients not undergoing breast reconstruction following mastectomy * patients undergoing delayed breast reconstruction following mastectomy * patients undergoing immediate definitive breast reconstruction after mastectomy * patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction * medical debility precluding surgical treatment * prior breast or chest wall irradiation * pregnant patients * male gender

Keywords: breast cancer cancer of breast reconstructive surgery
carbon ion radiotherapy for the treatment of localized prostate cancer

Conditions: Prostate Carcinoma

Summary: the aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy (cirt) for the treatment of in chinese localized prostate cancer

the purpose of this study is to determine the maximal tolerated dose (mtd) of cirt in the treatment of localized prostate cancer and to evaluate the efficacy of such treatment at the mtd. participants will be treated with cirt with escalating dose regimens to evaluate the maximal tolerated dose (mtd) in terms of acute and subacute toxicity observed during and within 6 months after the completion of cirt. once the mtd for localized prostate cancer is determined, the mtd will be used as the recommended dose to patients fulfilling the inclusion criteria in the phase ii part of the trial.

Eligibility criteria:
inclusion criteria: * pathologically confirmed adenocarcinoma of the prostate * no lymph node and distant metastasis * age ≥ 20 and \< 85 years of age * karnofsky performance score ≥70 * no previous pelvic radiation therapy (rt) * no previous prostatectomy * no previous invasive cancer (within 5 years before the prostate cancer diagnosis)except for skin non-melanoma cancer * ability to understand character and individual consequences of the clinical trial * willing to sign the written informed consent; informed consent must be signed before the enrollment in the trial exclusion criteria: * no pathologically confirmed adenocarcinoma of the prostate * pelvic lymph node metastasis (n1) * distant metastasis (m1) * urinary obstructive symptoms (ipss \> 20) * previous pelvic radiotherapy * previous prostatectomy * severe systemic disorders * concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, crohn disease), anti-coagulant treatment (warfarin, heparin) * previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer * non conformity of the radiotherapy dose distribution when compared to the dose constraints * psychiatric disorders or any other condition that can make unreliable the informed consent

Keywords: prostate carcinoma carbon-ion radiotherapy efficacy toxicity
adherence dynamics for whole food interventions in african-american men

Conditions: Healthy

Summary: the purposes of this study are to explore the dynamics of adherence, using a simple whole food intervention strategy, both prior to and during the intervention period and to identify nutrient shifts in self-selected diets and to determine health risks (blood pressure, hyperlipidemia, and body weight) that may have resulted from increased tomato product consumption.

african-american (aa) men suffer the greatest proportion of health disparities of any studied category and adherence to advice among this group has been vastly understudied. although there are several ongoing trials for behavioral change, either of diet or lifestyle, enrollment rates of aa men (\< 25%) often provide insufficient numbers to evaluate adherence issues separately. tomatoes, more than lycopene alone, may have beneficial effects on prostate health, including bph and prostate cancer. efficacy trials would require long-term adherence to high levels of tomato product (tp) consumption.

Eligibility criteria:
inclusion criteria: * african-american men aged ≥ 50 yr who recently were found to have serum prostate specific antigen (psa) concentrations of \>2.5 ng/ml with negative prostate biopsy for prostate cancer. * english literacy * willing to consume tomato products on a regular basis. exclusion criteria: * prostate cancer diagnosis * other cancers \< 5 yrs postdiagnosis except for melanoma * already consuming four 1/2 cup servings of tomato products/wk.

Keywords: prostate cancer prevention
sedation and postoperative cognitive functions

Conditions: Cognitive Impairment; Femoral Fractures

Summary: patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. patients who were given ketamine and dexmedetomidine for sedation were included in the study. the mini mental status tests of the patients measured on the first and third days of the operation in the preoperative period were determined from the hospital records and recorded.

patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. the cognitive functions of these patients, which were evaluated by a mini-mental test in the preoperative period, on the first and third days of surgery, were recorded from routine patient follow-up forms. sedation scores of the patients evaluated by intraoperative alertness/sedation scale (oaa/s) observer evaluation were recorded. intraoperative hemodynamic data were recorded. the interventions applied to the patient were performed by anesthesiologists who were not involved in the study according to their preferences as part of the routine. the researchers were not involved in any intervention performed on the patient, only the data were recorded.

Eligibility criteria:
inclusion criteria: * patients over the age of 65 who underwent surgery under spinal anesthesia due to hip fracture * volunteered to participate in the study exclusion criteria: * patients who are under the age of 65 * patients with known histories of dementia * patients with alzheimer's disease * patients with central nervous system disease * patients who scored 15 or less according to the mini mental status test (mmse) * patients who underwent surgery under general anesthesia * patients who refused to voluntarily participate in the study

Keywords: cognitive impairment mini mental status test hip fractures ketamine dexmedetomidine
t-helper 2 (th2) cytokine responses in overweight/obese subjects

Conditions: Overweight; Obesity

Summary: cytokines are chemicals that are naturally made by your body. certain cytokine levels are changed in the blood of patients who develop allergies and/or asthma. cytokine levels may also be changed in some individuals who are overweight or obese. the purpose of this study is to determine if certain cytokine levels differ based on a person's weight and whether or not they have allergies or asthma. information gathered in this study will be compared to information gathered from subjects who have participated in another similar study for patients who have allergies and/or asthma.

the aims of this study are to: 1. characterize the relationship between bmi and th2 skewing in non-atopic adult subjects. 2. compare these results to those previously obtained from atopic adult subjects it is expected that the results of this study will demonstrate enhanced th2 skewing in overweight and obese atopic subjects as compared to non-atopic subjects. it is further anticipated that the results of this study will be used as preliminary data to generate an nih grant application exploring the link between obesity and atopy.

Eligibility criteria:
inclusion criteria: * adults aged 18 to 50 years * pre-bronchodilator fev1 \> 80% predicted with no evidence of reversibility following administration of bronchodilator * no history of allergies exclusion criteria: * medical history consistent with atopy and/or asthma * any positive response to allergy skin testing for inhalant allergens (defined as a wheal \> 3 mm larger than the negative control) * a pre-bronchodilator fev1 \< 80% predicted * \> 12% reversibility in fev1 following administration of a bronchodilator * any history of significant chronic illness * history of respiratory infection within the past 2 weeks * any use of prescription medications other than oral contraceptives or thyroid hormone replacement within the past 2 months * use of any investigational medication within the past month

Keywords: healthy
efficacy of repetitive transcranial magnetic stimulation and cognitive behavioral therapy on heroin dependence

Conditions: Heroin Dependence

Summary: heroin dependence is one of most common substance dependence, which brings great burden on health worldwide. heroin dependence may lead to immunosuppression and cognitive impairments. once heroin dependence is developed, it will be difficult to recover and easy to relapse. although many efforts had been made in the treatment of heroin dependence, the annual recurrence of heroin dependence with traditional therapies would be up to 90%. repetitive transcranial magnetic stimulation (rtms) on the dorsolateral prefrontal cortex (dlpfc) or cognitive behavioral therapy (cbt) each alone was reported to have some effect on preventing from relapse of substance dependence. in order to test whether combined therapy of high frequency rtms (hf-rtms) with cbt is better for preventing from relapse of heroin dependence, we recruit patients with heroin dependence to participate this study. the study is a factorial designed and the patients will be assigned into one of the following six groups randomly: (1) regular treatment (symptomatic treatment) with blank tms; (2) regular treatment (rt) with blank tms and cbt; (3) rt with right dlpfc hf-rtms; (4) rt with right dlpfc hf-rtms and cbt; (5) rt with left dlpfc hf-rtms; (6) rt with left dlpfc hf-rtms and cbt. tms was given 5 days per week for total 2 weeks using uniform scheme (5 seconds of 10hz stimulation per train, 30 trains per day with inter-train interval of 20 seconds). cbt will be given once per week for total 8 weeks. the patients will be followed up for 6 months. recurrence of heroin dependence, duration of abstention, heroin/drug intake, craving for heroin and other cognitive psychological assessments will be recorded and compared among the 6 treatment groups and the efficacy of combined therapy of rtms with cbt will be evaluated in our study.


Eligibility criteria:
inclusion criteria: * diagnosis as heroin dependence according to dsm-iv criteria * no definite history of neurological diseases and psychological problems * volunteer to participate the study, cooperate to be followed up exclusion criteria: * acute withdrawal state and ciwa score \> 9 * with other neurological diseases and psychological problems * with ever brain trauma and damage * with other psychological medications or other substance dependence * with other contraindications to have transcranial magnetic stimulation

Keywords: heroin dependence, transcranial magnetic stimulation, cognitive behavioral therapy
the study in the correlation between the severity of post-stroke fatigue and the severity of qi deficiency and blood stasis

Conditions: Poststroke Fatigue

Summary: the purpose of the present study was to investigate the correlation between the severity of fatigue, and the severity of qi deficiency and blood stasis.

according to the reports of department of health, stroke has been the top three ranking in leading ten major mortality causes. although fatigue is a common symptom after stroke, but it is easy to neglect due to fatigue is a non-specific symptom. based on the literature review, fatigue symptom is not only common on post-stroke patient and it also has highly correlation with mortality, prognosis and efficacy of rehabilitation. in traditional chinese medicine recording, wang qing-ren suggests that the main etiology of stroke is results from qi stagnation and blood stasis, thereafter, the study about qi deficiency and blood stasis became to the main stream for stroke until now. therefore, the purpose of the present study was to investigate the correlation between the severity of fatigue, and the severity of qi deficiency and blood stasis.

Eligibility criteria:
inclusion criteria: 1. gender: men or women 2. age:40\~80 years old 3. stroke history at least 3 months 4. hemorrhage or ischemic stoke 5. conscious clear and can communicate 6. brief fatigue inventory-taiwan form score ≥ 4 7. sign informed consent exclusion criteria: 1. patient with psychotic diagnosis and can't cooperate with researcher 2. major disease: chronic obstructive pulmonary disease, heart failure, myocardial infarction, chronic renal failure, liver cirrhosis 3. pregnant women 4. breastfeeding women
recovery - a collaborative project

Conditions: Mental Health Impairment; Substance Abuse

Summary: in norway, official guidelines and policies state that recovery oriented services in the field of mental health and substance abuse services is a desirable goal. this collaborative research project aims to provide in-depth knowledge of how recovery oriented practices and collaboration in the mental health and substance abuse services in the municipality of new drammen develop over a three-year period. using qualitative methods, the main aim of the study is to explore what recovery orientation of services in mental health and substance abuse presupposes and involves related to roles, collaboration and knowledge. to explore these issues, service users will be interviewed together with their primary mental health professional. the study will also apply observational fieldwork in order to observe recovery oriented practices between service users and professionals and between professionals. an advisory group consisting of people with background as service users, mental health clinicians and service leaders will contribute throughout the project. .


Eligibility criteria:
1. adults who have received community mental health and / or substance abuse services for the past year or longer, due to moderate or severe mental health and / or substance abuse problems. inclusion criteria: * receives community mental health services due to mental health and /or substance abuse related problems * above 18 years old exclusion criteria: * under the age of 18 2. mental health workers in the municipality, working in mental health and substance abuse services
lipid biomarker study in men with dyslipidemia after simvastatin treatment (study mk-0000-140)(completed)

Conditions: Hypercholesterolemia, Dyslipidemia

Summary: the purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies.


Eligibility criteria:
inclusion criteria: * participant is a caucasian (including hispanic) male * participant has a maximum waist size of 40 inches * participant does not currently use any lipid-altering medications * participant is in good health other than the diagnosis of dyslipidemia exclusion criteria: * participant has had stomach ulcers within the last 3 months * participant has had a heart attack in the last 6 months or has angina * participant has chronic heart failure * participant has a history of stroke, seizures, or major neurological disorder * participant has a history of cancer * participant has a gastrointestinal condition that affects bowel movements * participant has type 1 or 2 diabetes

Keywords: hypercholesterolemia, dyslipidemia, simvastatin, zocor
knowledge of living will in patients with rheumatic diseases

Conditions: Rheumatic Disorder

Summary: the living will is a legal document derived from a communication and deliberation process, medical ethical aspect, currently regulated in mexico by the general health law and the health law of mexico city. knowledge of living will in the population with chronic diseases, including rheumatic diseases, has been little addressed. most patients do not know what the living will document is, so they do not carry it out and others, despite knowing it, have a passive attitude toward doing it.

a study will be carried out on patients with rheumatic diseases and healthy family controls. patients will be selected from those attending the department of immunology and rheumatology in mexico city outpatient department, including consecutive cases. the patients will be assessed for their quality of life and disability. patients and controls will be evaluated on the knowledge of living will, their perceptions about specific health outcomes, sociodemographic characteristics, comorbidities, and psychiatric pathology.

Eligibility criteria:
inclusion criteria: cases * patients with a rheumatic disease diagnostic by a rheumatologist * patients with rheumatic diseases attending the department of immunology and rheumatology in mexico city outpatient department * patients who agree to participate in the study, who complete and sign the informed consent controls * relative of a patient with rheumatic diseases of the same sex and age ± 5 years, without known rheumatic and/or chronic disease and without the use of pharmacological treatment for more than 7 days during the month before study entry. exclusion criteria: cases * patients with severe diseases or in palliative care by a rheumatologist controls - withdrawal of the study

Keywords: rheumatic diseases living will
the effects of oscillatory positive expiratory pressure (opep) therapy in patients with copd

Conditions: COPD

Summary: the goal of this non-pharmacologic interventional study is to learn if oscillatory positive expiratory pressure (opep) therapy can improve disease impact and respiratory system dynamics in patients with copd. the main questions it aims to answer are: is opep therapy able to improve the impact of cough symptoms as measured on a validated symptom score? is opep therapy able to improve the properties of the lung (called reactance) as measured by oscillometry? researchers will compare the results of the same tests performed before and after 4 weeks of opep treatment to see if opep treatment improves cough symptoms and lung mechanics. * participants with copd will complete in-person baseline tests and will then receive the smart opep device. * these participants will then use the smart opep device at home, at least twice a day, for 4 consecutive weeks. * finally, these participants will return to complete in-person end-of-study tests.

the objectives of this prospective, non-pharmacologic interventional cohort study are to determine the effect of four consecutive weeks of twice-daily or greater opep usage among patients with copd with a chronic bronchitis (sputum-producing) phenotype on disease impact and on respiratory system dynamics. a 'dose-response' effect of opep use will also be investigated. we hypothesize that a 4-week period of opep therapy among eligible patients with copd with a chronic bronchitis (sputum-producing) phenotype will be associated with improved disease impact scores and airway mechanics.

Eligibility criteria:
inclusion criteria: 1. males and females 40 years of age or more 2. former/current smokers with a cigarette smoking history for 10 or more pack-years 3. physician diagnosis of copd previously confirmed by spirometry (fev1/fvc less than 0.7) with 'mild' to 'very severe' (i.e. gold 1-4) copd 4. chronic bronchitis phenotype: sputum production or presence of productive cough greater than 2 days/week in the last 3 months for at least 2 consecutive years, or presence of cough and phlegm almost every day or several times per week 5. ability to participate without supplemental oxygen during all oscillometry testing 6. ability to provide informed consent exclusion criteria: 1. no copd diagnosis 2. bronchiectasis, cystic fibrosis, or any other known suppurative acute/chronic lung disease as the principal respiratory condition 3. physician-diagnosed exacerbation and/or hospitalization for pulmonary symptoms in the 4 weeks preceding baseline testing 4. current use of opep, or any use of opep in the 4 weeks preceding baseline testing 5. current or recent participation in a standard pulmonary rehabilitation program in the 4 weeks preceding baseline testing or during the study

Keywords: copd opep chronic bronchitis disease impact reactance casa-q questionnaire oscillometry
effects of telmisartan by ambulatory blood pressure monitoring (abpm) in chinese patients with mild to moderate essential hypertension

Conditions: Hypertension

Summary: to assess the trough/peak ratio of 40 mg telmisartan tablet by ambulatory blood pressure monitoring in chinese patients with mild to moderate essential hypertension


Eligibility criteria:
inclusion criteria: * chinese male or female aged 18 to 75 years * mild to moderate hypertension defined as a morning dbp _95 and \<110 mm hg at visit1 and visit 2. mean sitting systolic pressure (sbp) must be \<180 mm hg * ability to provide written informed consent exclusion criteria: * women who are pregnant or breast-feeding, or of childbearing potential without an effective method of birth control (effective birth control methods are: uterine device, surgical sterilisation, progestogens alone) * known or suspected secondary hypertension * known history of any chronic hepatic disease * bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant * new york heart association (nyha) functional class congestive heart failure (chf) iii-iv * unstable angina pectoris * myocardial infarction or percutaneous transluminal coronary angiography (ptca) or cardiac surgery within the preceding three months * clinical relevant cardiac arrhythmias as determined by the clinical investigator * hypertrophic obstructive cardiomyopathy or clinically significant valvular disease * evidence of retinal hemorrhages/exudates * clinical significant hyperkalemia as defined by serum potassium level \>6.0 milliequivalents (meq)/l * insulin-dependent diabetes mellitus * non-insulin-dependent diabetes mellitus with poor glucose control as defined by persistent fasting blood sugar \>200 mg/dl, peripheral neuropathy or autonomic neuropathy * known drug or alcohol dependency * administration of any diuretic, ace inhibitor or angiotensin ii receptor antagonist within two weeks before run-in period * administration of medication known to affect blood pressure during trial period * patients receiving any investigational therapy within one month of signing the informed consent form * known hypersensitivity to any component of the formulation * any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of trial medication